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EP4573568A1 - Systèmes d'emballage intelligents avec stockage élastique non volatil - Google Patents

Systèmes d'emballage intelligents avec stockage élastique non volatil

Info

Publication number
EP4573568A1
EP4573568A1 EP24742325.4A EP24742325A EP4573568A1 EP 4573568 A1 EP4573568 A1 EP 4573568A1 EP 24742325 A EP24742325 A EP 24742325A EP 4573568 A1 EP4573568 A1 EP 4573568A1
Authority
EP
European Patent Office
Prior art keywords
packaging
information
surgical
parameters
data
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24742325.4A
Other languages
German (de)
English (en)
Inventor
Iv Frederick E. Shelton
Jacqueline C. ARONHALT
Brian Schings
Gregory J. Bakos
Jason Rector
Matthew D. COWPERTHWAIT
Shane R. Adams
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cilag GmbH International
Original Assignee
Cilag GmbH International
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cilag GmbH International filed Critical Cilag GmbH International
Priority claimed from PCT/IB2024/056618 external-priority patent/WO2025012786A1/fr
Publication of EP4573568A1 publication Critical patent/EP4573568A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B13/00—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion
    • G05B13/02—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric
    • G05B13/0205—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric not using a model or a simulator of the controlled system
    • G05B13/024—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric not using a model or a simulator of the controlled system in which a parameter or coefficient is automatically adjusted to optimise the performance
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
    • G06K17/00—Methods or arrangements for effecting co-operative working between equipments covered by two or more of main groups G06K1/00 - G06K15/00, e.g. automatic card files incorporating conveying and reading operations
    • G06K17/0022—Methods or arrangements for effecting co-operative working between equipments covered by two or more of main groups G06K1/00 - G06K15/00, e.g. automatic card files incorporating conveying and reading operations arrangements or provisions for transferring data to distant stations, e.g. from a sensing device
    • G06K17/0029—Methods or arrangements for effecting co-operative working between equipments covered by two or more of main groups G06K1/00 - G06K15/00, e.g. automatic card files incorporating conveying and reading operations arrangements or provisions for transferring data to distant stations, e.g. from a sensing device the arrangement being specially adapted for wireless interrogation of grouped or bundled articles tagged with wireless record carriers
    • G—PHYSICS
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    • G06K19/06—Record carriers for use with machines and with at least a part designed to carry digital markings characterised by the kind of the digital marking, e.g. shape, nature, code
    • G06K19/067—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components
    • G06K19/07—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components with integrated circuit chips
    • G06K19/0723—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components with integrated circuit chips the record carrier comprising an arrangement for non-contact communication, e.g. wireless communication circuits on transponder cards, non-contact smart cards or RFIDs
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    • G06K19/06—Record carriers for use with machines and with at least a part designed to carry digital markings characterised by the kind of the digital marking, e.g. shape, nature, code
    • G06K19/067—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components
    • G06K19/07—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components with integrated circuit chips
    • G06K19/077—Constructional details, e.g. mounting of circuits in the carrier
    • G06K19/07749—Constructional details, e.g. mounting of circuits in the carrier the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card
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    • G06K7/10—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation
    • G06K7/10009—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves
    • G06K7/10019—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves resolving collision on the communication channels between simultaneously or concurrently interrogated record carriers.
    • G06K7/10079—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves resolving collision on the communication channels between simultaneously or concurrently interrogated record carriers. the collision being resolved in the spatial domain, e.g. temporary shields for blindfolding the interrogator in specific directions
    • G06K7/10089—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves resolving collision on the communication channels between simultaneously or concurrently interrogated record carriers. the collision being resolved in the spatial domain, e.g. temporary shields for blindfolding the interrogator in specific directions the interrogation device using at least one directional antenna or directional interrogation field to resolve the collision
    • G06K7/10099—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves resolving collision on the communication channels between simultaneously or concurrently interrogated record carriers. the collision being resolved in the spatial domain, e.g. temporary shields for blindfolding the interrogator in specific directions the interrogation device using at least one directional antenna or directional interrogation field to resolve the collision the directional field being used for pinpointing the location of the record carrier, e.g. for finding or locating an RFID tag amongst a plurality of RFID tags, each RFID tag being associated with an object, e.g. for physically locating the RFID tagged object in a warehouse
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G06Q10/083—Shipping
    • G06Q10/0832—Special goods or special handling procedures, e.g. handling of hazardous or fragile goods
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G06Q10/083—Shipping
    • G06Q10/0833—Tracking
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G06Q10/087—Inventory or stock management, e.g. order filling, procurement or balancing against orders
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q30/00—Commerce
    • G06Q30/018—Certifying business or products
    • G—PHYSICS
    • G08—SIGNALLING
    • G08B—SIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
    • G08B5/00—Visible signalling systems, e.g. personal calling systems, remote indication of seats occupied
    • G08B5/22—Visible signalling systems, e.g. personal calling systems, remote indication of seats occupied using electric transmission; using electromagnetic transmission
    • G08B5/36—Visible signalling systems, e.g. personal calling systems, remote indication of seats occupied using electric transmission; using electromagnetic transmission using visible light sources
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09G—ARRANGEMENTS OR CIRCUITS FOR CONTROL OF INDICATING DEVICES USING STATIC MEANS TO PRESENT VARIABLE INFORMATION
    • G09G3/00—Control arrangements or circuits, of interest only in connection with visual indicators other than cathode-ray tubes
    • G09G3/20—Control arrangements or circuits, of interest only in connection with visual indicators other than cathode-ray tubes for presentation of an assembly of a number of characters, e.g. a page, by composing the assembly by combination of individual elements arranged in a matrix no fixed position being assigned to or needed to be assigned to the individual characters or partial characters
    • G09G3/34—Control arrangements or circuits, of interest only in connection with visual indicators other than cathode-ray tubes for presentation of an assembly of a number of characters, e.g. a page, by composing the assembly by combination of individual elements arranged in a matrix no fixed position being assigned to or needed to be assigned to the individual characters or partial characters by control of light from an independent source
    • G09G3/3433—Control arrangements or circuits, of interest only in connection with visual indicators other than cathode-ray tubes for presentation of an assembly of a number of characters, e.g. a page, by composing the assembly by combination of individual elements arranged in a matrix no fixed position being assigned to or needed to be assigned to the individual characters or partial characters by control of light from an independent source using light modulating elements actuated by an electric field and being other than liquid crystal devices and electrochromic devices
    • G09G3/344—Control arrangements or circuits, of interest only in connection with visual indicators other than cathode-ray tubes for presentation of an assembly of a number of characters, e.g. a page, by composing the assembly by combination of individual elements arranged in a matrix no fixed position being assigned to or needed to be assigned to the individual characters or partial characters by control of light from an independent source using light modulating elements actuated by an electric field and being other than liquid crystal devices and electrochromic devices based on particles moving in a fluid or in a gas, e.g. electrophoretic devices
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • G—PHYSICS
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    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W4/00—Services specially adapted for wireless communication networks; Facilities therefor
    • H04W4/02—Services making use of location information
    • H04W4/029—Location-based management or tracking services
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0803—Counting the number of times an instrument is used
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09G—ARRANGEMENTS OR CIRCUITS FOR CONTROL OF INDICATING DEVICES USING STATIC MEANS TO PRESENT VARIABLE INFORMATION
    • G09G2380/00—Specific applications
    • G09G2380/04—Electronic labels
    • G—PHYSICS
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    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Definitions

  • the present disclosure relates generally to smart surgical devices, systems, and methods.
  • systems include a manufacturer-sealed sterile surgical packaging containing a surgical instrument configured to be used in a surgical procedure, a graphical display, at least one data processor in operable communication with the graphical display, and memory in operable communication with the at least one data processor, and storing instructions configured to cause the at least one data processor to perform operations.
  • the operations can include storing parameters corresponding to the surgical instrument, receiving a data set characterizing parameters associated with the surgical instrument, adjusting based on the received data, the catalogued parameters, determining a graphical depiction characterizing the adjusted parameters, and providing the graphical depiction of the adjusted parameters on the graphical display.
  • the cataloged parameters and adjusted parameters include information characterizing at least one of historic states, future states, and operational information.
  • the historic states can include at least one of manufacturing information, materials and components information, geographical origin information, and environmental information experienced by the surgical packaging.
  • the future states can include at least one of an intended destination information, environmental requirements information, customs information, disposal information, and error reporting procedures information.
  • the operational information can include at least one of product compatibility information, expected lifecycle information, and operational instructions.
  • the operations can further comprise providing, based on an on- demand user request, at least a portion of the catalogued parameters.
  • the on-demand user request can require an authentication to access the catalogued parameters.
  • the graphical display can include at least one e-ink label.
  • the adjusted parameters can be transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed sterile surgical packaging.
  • a method including storing parameters corresponding to a surgical instrument, the surgical instrument contained within a manufacturer-sealed sterile surgical packaging, the manufacturer-sealed sterile surgical packaging including a display disposed thereon, receiving, a data set characterizing parameters associated with the surgical instrument, adjusting, based on the received data, the stored parameters, determining a graphical depiction characterizing the adjusted parameters, and providing the graphical depiction of the adjusted parameters on the display.
  • the cataloged parameters and adjusted parameters can include information characterizing at least one of historic states, future states, and operational information.
  • the historic states can include at least one of manufacturing information, materials and components information, geographical origin information, and environmental information experienced by the surgical packaging.
  • the future states can include at least one of an intended destination information, environmental requirements information, customs information, disposal information, and error reporting procedures information.
  • the operational information can include at least one of product compatibility information, expected lifecycle information, and operational instructions.
  • the method can include providing, based on an on-demand user request, at least a portion of the cataloged parameters.
  • the on-demand user request can be authenticated prior to providing the at least a portion of the cataloged parameters.
  • the at least one display can include at least one e-ink label.
  • Non-transitory computer program products are also provided.
  • a non- transitory computer program product can store instructions which, when executed by at least one data processor forming part of at least one computing system, cause the at least one data processor to implement operations including storing parameters corresponding to a surgical instrument, the surgical instrument contained within a manufacturer-sealed sterile surgical packaging, the manufacturer-sealed sterile surgical packaging including a display disposed thereon, receiving, a data set characterizing parameters associated with the surgical instrument, adjusting, based on the received data, the catalogued parameters, determining a graphical depiction characterizing the adjusted parameters, and providing the graphical depiction of the adjusted parameters on the display.
  • systems include a manufacturer-sealed sterile surgical packaging containing a surgical instrument configured to be used in a surgical procedure, a graphical display, at least one data processor in operable communication with the graphical display, and memory in operable communication with the at least one data processor, and storing instructions configured to cause the at least one data processor to perform operations.
  • the operations can include recording historical data points of the surgical instrument, determining a degradation level of the surgical instrument based on the historical data point, determining an altered set of operating parameters based on the degradation level of the surgical instrument, and providing the altered set of operating parameters.
  • the system can vary in a number of ways.
  • the recording of historical data points can include tracking the amount of sterilization procedures the surgical instrument has underwent.
  • the recording of historical data points can include tracking the amount of operations performed by the surgical instrument.
  • the recording of historical data points can include tracking the environmental conditions where the surgical instrument is located.
  • the altered set of operating parameters can increase an operational accuracy of the surgical instrument.
  • the altered operating parameters can be transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed sterile surgical packaging.
  • a method in another embodiment, can include recording historical data points of a surgical instrument contained within a manufacturer-sealed sterile surgical packaging, the surgical instrument configured to be used in a surgical procedure, determining a degradation level of the surgical instrument based on the historical data points, determining an altered set of operating parameters based on the degradation level of the surgical instrument, and providing the altered set of operating parameters.
  • the method can vary in a number of ways.
  • the method can include deactivating the first transceiver prior to activating the second transceiver.
  • the method can include deactivating the second transceiver prior to activating the first transceiver.
  • the first transceiver can be at least one RFID chip embedded within the manufacturer-sealed, sterile surgical packaging.
  • the method can also include recording historical data points of the surgical instrument provided to the second transceiver via at least one sensor disposed in the surgical packaging.
  • the method can include adjusting operating parameters transmitted by the second transceiver based on the recorded historical data points.
  • the method can include constantly powering the second transceiver via the power supply.
  • the method can include actuating a switch positioned between the power source and the second transceiver to selectively activate the second transceiver.
  • the surgical instrument can be positioned within a first compartment within the manufacturer-sealed, sterile surgical packaging, and the power source is positioned within a second compartment within the manufacturer-sealed, sterile surgical packaging, separate from the first compartment.
  • systems include a manufacturer-sealed sterile surgical packaging containing a surgical instrument, a graphical display disposed on the manufacturer-sealed sterile surgical packaging, a data processor disposed in the surgical packaging, and memory in operable communication with the data processor, the memory storing instructions configured to cause the at least one data processor to perform operations.
  • the operations include storing a plurality of display information sets corresponding to the surgical instrument, receiving a data set including a stage along a supply chain progression, determining, based on the received location along the supply-chain progression, a graphical depiction characterizing at least one of the plurality of stored display information sets, and providing the graphical depiction of the determined at least one display information set on the graphical display.
  • the at least one display can include at least one e-ink label.
  • the plurality of display information sets can include information characterizing at least one of manufacturing states, transit states, and operational information.
  • the manufacturing states can include at least one of manufacturing information, materials and components information, and geographical storage information.
  • the transit states can include at least one of an intended destination information, handling information, and customs information.
  • the operational information can include at least one of intended destination information, intended user information, and operational instructions.
  • a power supply can be contained within the manufacturer-sealed sterile surgical packaging, and configured to power the display.
  • the operations can include to receive data characterizing a stage of the supply-chain progression of the system, to determine a corresponding display information set from the plurality of display information sets, and providing the determined display information set via the display.
  • at least one of the display information sets can include a scanable code.
  • the received data set can include environmental parameters the manufacturer-sealed sterile surgical packaging is present within.
  • the graphical depiction on the graphical display can be adjusted when the manufacturer-sealed sterile surgical packaging passes to a second stage along the supply-chain progression.
  • a method in another embodiment, includes storing a plurality of display information sets corresponding to a surgical instrument, the surgical instrument contained within a manufacturer-sealed sterile surgical packaging, the manufacturer-sealed sterile surgical packaging including a graphical display disposed thereon, receiving a data set including a stage along a supply chain progression, determining, based on the received location along the supplychain progression, a graphical depiction characterizing at least one of the plurality of stored display information sets, and providing the graphical depiction of the determined at least one display information set on the graphical display.
  • the at least one display can include at least one e-ink label.
  • the plurality of display information sets can include information characterizing at least one of manufacturing states, transit states, and operational information.
  • the manufacturing states can include at least one of manufacturing information, materials and components information, and geographical storage information.
  • the transit states can include at least one of an intended destination information, handling information, and customs information.
  • the operational information can include at least one of intended destination information, intended user information, and operational instructions.
  • a power supply can be contained within the manufacturer-sealed sterile surgical packaging, and configured to power the display.
  • the method can include receiving data characterizing a stage of the supply-chain progression of the system, determining a corresponding display information set from the plurality of display information sets, and providing the determined display information set via the display.
  • at least one of the display information sets can include a scanable code.
  • the graphical depiction on the graphical display can be adjusted when the manufacturer-sealed sterile surgical packaging passes to a second stage along the supply-chain progression.
  • the determined compatible primary packaging can be provided on the second display of the secondary packaging.
  • the method can further include providing, based on the determined compatible secondary packaging, operational information for the primary packaging and compatible secondary packaging.
  • the operational information can include at least one of product compatibility information and operational instructions.
  • a non-transitory computer program product is provided. The non-transitory computer program product can store instructions which, when executed by at least one data processor forming part of at least one computing system, cause the at least one data processor to implement operations.
  • FIG. 1 is a top view of a passive RFID tag, according to an embodiment
  • FIG. 2 is a side schematic view of a smart packaging system containing a surgical instrument according to an embodiment
  • FIG. 3B is a diagram of a supply chain for a smart packaging system, according to an embodiment
  • FIG. 5 is a schematic view of a serial number for a smart packaging system containing a surgical instrument according to an embodiment
  • FIG. 13 is a side view of the smart packaging system of FIG. 11;
  • FIG. 14 is a schematic view of a smart packaging system, according to an embodiment
  • FIG. 15 is a schematic view of the smart packaging system of FIG. 14;
  • FIG. 16 is a perspective view of a smart packaging system, according to an embodiment
  • FIG. 18 is a side view of the smart packaging system of FIG. 16;
  • FIG. 20 is a side view of a mechanical sensor, according to an embodiment, of the smart packaging system of FIG. 19;
  • FIG. 21 is a side view of the mechanical sensor of FIG. 20;
  • FIG. 22 is a perspective view of mechanical sensor of a smart packaging system, according to an embodiment; [0055] FIG. 23 is a side view of the mechanical sensor of FIG. 22;
  • FIG. 24 is a schematic view of a gastric sleeve surgical procedure
  • FIG. 25 is a schematic view of a smart packaging system, according to an embodiment
  • FIG. 26 is a schematic view of a loading device of the smart packaging system of FIG. 25;
  • FIG. 27 is a schematic view of the loading device of FIG. 26.
  • FIG. 28 is a schematic view of the loading device of FIG. 26.
  • like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon.
  • linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods.
  • a person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape.
  • a dimension may not be a precise value but nevertheless be considered to be at about that value due to any number of factors such as manufacturing tolerances and sensitivity of measurement equipment. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the size and shape of components with which the systems and devices will be used.
  • Smart surgical devices, systems, and methods are provided.
  • the use of smart devices, systems, and methods can generally enable the storing, sharing, and utilization of information throughout a supply chain, as well as to assist in the management of various systems, procedures, and aspects of healthcare facilities in which they are used.
  • information directed to aspects of the supply chain and of healthcare facilities can be logged, monitored, and reviewed in order to adjust facets of the supply chain and/or healthcare facilities in real time.
  • analysis of the compiled information can be used in order to minimize or avoid pitfalls and issues associated with the supply chain and/or products flowing through the supply chain, as well as to minimize or avoid pitfalls and issues associated with the coordination of surgical procedures and associated devices at healthcare facilities.
  • smart devices, systems, and methods can improve the efficiency of the supply chain through the management of information associated with products flowing through that supply chain, and they can improve the efficiency of the healthcare facilities in which they are deployed for use in surgical procedures. While the specific types of smart devices, systems, and methods can vary, in some aspects the packaging of the products themselves can be leveraged in order to consistently track, monitor, and record information associated with the products. Further, tracking devices (e.g., scanners, beacons, etc.) and/or a centralized computer management system can be employed as part of the smart systems and devices.
  • tracking devices e.g., scanners, beacons, etc.
  • a centralized computer management system can be employed as part of the smart systems and devices.
  • the use of smart devices, systems, and methods can also impact the operations of a healthcare provider, such as during a surgery involving the smart surgical devices.
  • Information can be recorded, stored, monitored, and acted upon before, during, and after a surgical procedure involving the smart surgical device in order to improve the performance and to minimize the operational risks of the smart surgical device and of future smart surgical devices.
  • Smart devices including smart packaging systems, can act on the information they receive to provide recommendations, warnings, guidelines, and other information to various personnel associated with healthcare facilities.
  • This provided information can contemplate all aspects of daily procedures at healthcare facilities, including scheduling, logistics, coordination of surgical procedures, recommended handling instructions during specific surgical procedures, and more.
  • the smart devices and smart packaging systems themselves can be designed to include various physical aspects intended to assist personnel in acting upon the provided information.
  • the smart devices, systems, and methods can utilize smart packaging systems, which can be included on an outer packaging containing one or more surgical instruments.
  • the outer packaging can include a power source, one or more radio frequency identification (“RFID”) tags, and one or more sensors capable of measuring environmental aspects.
  • RFID radio frequency identification
  • the one or more RFID tags can take on various forms and may generally include passive and active RFID tags.
  • Passive RFID tags can include an RFID chip (or integrated circuit, “IC”), an antenna, and a substrate.
  • the IC contains a logical control unit, memory, and transceiver, which can be used for decoding, decrypting, and error checking.
  • the antenna is used to receive/transmit information, such as electronic data, to and from an external electronic system with its own reception and/or transmission capabilities (e.g., a reader).
  • the substrate holds the chip and antenna together and provides the RFID tag with structure.
  • Passive RFID tags can receive power in the form of electromagnetic energy (e.g., radio energy) transmitted by a reader and received by the antenna of the passive RFID tag.
  • An example of a passive RFID tag 30 can be seen in FIG. 1.
  • the passive RFID tag 2 includes an IC 4 electronically coupled to an antenna 6.
  • the IC 4 and the antenna 6 are mounted on a substrate 8.
  • Active RFID tags may include components similar to those of passive RFID tags with the addition of a separate power source (e.g., an integrated battery). Further, in some variations, other kinds of sensors or chips, such as near field communication (NFC) sensors, may be used in addition to, or in place of, the one or more RFID tags.
  • NFC near field communication
  • the outer packaging can include additional memory storage and/or one or more additional processors in electronic communication with the one or more RFID tags in order to increase the capabilities of the RFID tags.
  • the smart packaging system can also include one or more of a display, such as an e-ink display, LCD display, touchscreen, or equivalent, and/or a readable medium, such as a barcode, QR code, or equivalent.
  • the smart packaging system can include data ports, such as USB-type ports.
  • the smart packaging system can generally be capable of taking in data from external sources, such as computers, computer networks, and data received from its one or more sensors, and the smart packaging system can generally be capable of transmitting data and/or presenting information to computers, computer networks, users, scanning devices, RFID readers, and any device capable of receiving data from features of the smart packaging system.
  • the surgical instrument(s) and/or surgical components contained within the outer packaging can vary in both form and function.
  • the entire surgical instrument can be a “smart” instrument in which the status and operations of the surgical instrument can be monitored, recorded, and altered at any time. For example, if the surgical instrument is an endocutter configured to incise and staple tissue, an amount of torque applied by the jaws of the instrument can be monitored throughout a surgical procedure. If it is determined by the HUB that too much torque is being applied by a surgeon, a maximum torque limit can be imposed wirelessly on the instrument in real time so as to prevent the occurrence of an accident.
  • FIG. 2 An example of a smart packaging system 10 is depicted in FIG. 2.
  • the illustrated smart packaging system 10 includes a packaging 12 containing a surgical instrument 14 therein.
  • the surgical instrument 14 can be any surgical instrument or surgical material, such as an endocutter as shown.
  • the smart packaging system 10 can include a controller 13 that is configured to execute functions of the smart packaging system 10.
  • the controller 13 can generally include a control unit 13 A, a logic unit 13B, and a memory 13C that enable functionality of the controller 13.
  • the smart packaging system 10 can also include an internal power source 15, such as a battery, that is capable of providing power to various components of the smart packaging system 10, including the controller 13, described herein.
  • the packaging 12 can also include an RFID tag 16 configured to transmit and receive information from an external source.
  • the rest of the characters in the serial number can be used repeatedly to create multiples of the primary number to substantially increase the number of unique identifiers.
  • the serial number under one hash decryption can define operational constants of the product. Under a separate hash decryption, the serial number can define assembly & parts tractability.
  • all of the characters and symbols of the serial number in native format can provide the unique identifier of the packaging itself to the HUB 50. In this way the product data, its metadata, and its unique identifier can all be embedded within the serial number itself allowing the serial number to inform a user of both what instrument is in the packaging, and how to use the instrument all at the same time. This can also result in non-sequential serial numbers from one product packaging to the next due to the intensity of data within the serial number.
  • a serial number on the packaging can be used to store a large density of data using encryption.
  • the serial number can also include scanable QR codes or bar codes to pull even more stored data from a remote data source, where the scanable code can be altered by the HUB 50 to show different codes, which pull up different sets of information when scanned, as the packaging moves through the supply-chain.
  • the scanable code can be used to access the history and operational data of an instrument. Methods of scanning can include manual scanning, active wireless transmission by capable devices, direct detection, geo-fencing, BLE beacons, and by surgical step.
  • harmonic device data can be recorded into the cloud database (i.e., frequency, impedance, capacitance, etc.).
  • historical data points can include motor and electrical characterizations, staple height, and frictional coefficient in a moving shaft, such that algorithmic adjustments can be made to optimize device based on this recorded device data.
  • An example of optimization can include a stapler cartridge recommendation based on the device assembly data of a stapler which a surgeon has chosen to use for a surgical procedure.
  • the expiration status of an instrument can be passively determined by arranging a printed barcode on a shaft or jaw of stapler or energy device in view of a laparoscope.
  • Video imaging from the laparoscope can be used to check expiration in real-time during the surgical procedure, and then alert user.
  • This kind of monitoring can function in a number of ways, such as relying on a specific visual indicator present on an object to constantly track that object.
  • a packaging of surgical needles can include a specific pattern or scanable code that is related to an expiration date.
  • a camera included in the systems can be relied on to visually monitor an area for that specific pattern, even at multiple angles. When the pattern is detected, the expiration date of the instrument object can checked in real-time.
  • multiple scanable codes can be used to determine the compatibility of sub-assemblies contained in separate packaging.
  • packaging codes are accessible on the exterior of a packaging while sealed so that information is communicated and indicated prior to opening the packaging to maintain sterility in the event a different option is chosen once compatibility is checked.
  • the first code of a combination sub-device prompts the user to scan the code of the compatible sub-device, so that a comparison can be made between the two devices. In the event compatibility is not determined after scanning of the codes, the user can be able to override the request if desired.
  • Bluetooth low energy (“BLE”) beacons can be employed for another kind of technique for object monitoring.
  • the BLE beacons can repeatedly transmit a signal that other devices can detect, such as via a radio signal.
  • the signal can comprise an encoded message of letters and numbers transmitted on short intervals, which can be used for specific transmissions and to encode specific messages and data.
  • the BLE beacons can be used to register products currently located in an operating room, and they can also be used to communicate status changes of detected objects and products.
  • the smart packaging system 10 can contain one or more methods to alter a bandwidth of its transmissions, as well as multiple methods of communication. Some of the methods of communication can rely on the internal power source 15 of the smart packaging system 10. Some methods can derive power from an external source, such as an external electro-magnetic field, such as with near field communication (NFC), or with an external wired connection, such as via a USB cable or the like.
  • an external source such as an external electro-magnetic field, such as with near field communication (NFC), or with an external wired connection, such as via a USB cable or the like.
  • the smart packaging system 10 can rely on RFID tags to communicate with other devices, but if RFID becomes unavailable, the smart packaging system can rely on secondary means of communication.
  • NFC and RFID could be combined such that, with RFID, power is obtained from an external field and broadcasting only occurs when the system is prompted.
  • an antenna can be used, and upon activation, other systems, such as WIFI and battery systems, can be deactivated to save power.
  • active and passive compatibility checks can be contained within the packaging.
  • a packaging 1052 with an active electronic chip 1053 powered by a battery positioned within the packaging
  • another packaging 1050 with a passive electronic chip 1054 e.g., an RFID tag
  • the active chip 1053 and passive chip 1054 act as transceivers which can communicated with surrounding sub-assembly packaging when in close proximity to automatically check compatibility among the sub-assemblies.
  • one of the packaging for example the packaging containing the power supply, can also include a feedback device in the form of a speaker 1056, or different colored LEDs 1058, 1060 in order to give feedback on compatibility to the user.
  • the feedback devices can be activated to alert a user to the compatibility of the subassemblies.
  • both packaging can include passive chips, which have to be scanned by a user in order to determine compatablity between the sub-assemblies.
  • the scanning of the passive chips can be performed in a way that has minimal disruption on a surgical procedure.
  • the chip in each packaging can be scanned automatically upon entry to an operating room though a central transceiver, such as the HUB 50.
  • An active global geo-fence is another kind of technique for object monitoring.
  • An active global geo-fence can be assigned to a specific geo-physical location, and all objects passing through that fence can be tracked.
  • a combination of systems can be combined to monitor objects passing through this fence, such that the combination of systems can detect objects in a combined device or as separated elements.
  • the system 10 then gives visual and/or audible feedback on compatibility of the devices.
  • an optical sensor such as a camera on a smart device, can be used to take picture of the packaging or scan a scanable code or RFID tag with the smart device in order to determine compatibility.
  • Additional types of technologies that can be used in the packaging can include Radio Frequency (RF), High Frequency (HF), Ultra High Frequency (UHF), Near Field Communication (NFC), where passive read range up to ⁇ 25m, and active read ranges are up to ⁇ 100m.
  • RF Radio Frequency
  • HF High Frequency
  • UHF Ultra High Frequency
  • NFC Near Field Communication
  • the system 10 can also provide a list of additional compatible devices in order to optimize the operation of an instrument.
  • the system 10 can determine alternative sub-assemblies if the system 10 determines that a chosen sub-assembly, while it may be compatible, is not the best choice for a specific procedure.
  • the list of compatible components can include trade-off options between speed, cost, complications (e.g. RF vs. endocutter) of different compatible sub-assemblies.
  • types of compatible comparisons for staplers can include reload staple material compared to a subsequent reload, compatibility of shaft to handle, or handle to adapter, or shaft to adapter, or buttress compatibility.
  • examples of types of compatible comparisons for energy device can include harmonic energy device blades to handpiece, energy RF device or blade to handpiece, energy device to generator, return pad to generator.
  • the system 10 can also provide indicators to a user for selecting a compatible sub-assembly.
  • the system 10 can include smart storage that highlights the product codes that are compatible with instruments/sub-assemblies already pulled.
  • the smart storage can utilize the feedback devices already present in the packaging of a sub-assembly.
  • each packaging can have an LED that lights up in response to a wireless signal sent through a smart device when looking for a specific compatible component (e.g., select on a phone app that a user is looking for reloads for a specific stapler, and then all the different types of staple cartridge reloads compatible with that stapler can light up while on the shelf in a storage area.
  • a specific compatible component e.g., select on a phone app that a user is looking for reloads for a specific stapler, and then all the different types of staple cartridge reloads compatible with that stapler can light up while on the shelf in a storage area.
  • the packaging of the stapler can also include a transceiver in the packaging.
  • a transceiver in the packaging.
  • augmented reality can be used to locate compatible packaging using a headset or smart device app that highlights the product codes that are being searched for or that are compatible with products already pulled for use in a surgical procedure.
  • the system 10 can be used to determine if an instrument has been repackaged.
  • the system 10 can read a serial number or scanable code on the packaging, and compare it to a database that contains all the matching combinations of a particular instrument and its corresponding packaging. If the instrument is put in a new packaging, the codes will not match, and the system 10 can let the customer know the device has been repackaged through visual or audio feedback. This can also enable a manufacturer to reprocess devices and update the database with the new packaging codes.
  • the system 10 can offer suggestions to users in order to increase operational efficiency. Suggestions can be made to a user based on the scanned instruments within a packaging.
  • the information can be based on cloud data available from a large body of users, or can be tailored to be a dataset just from that single user so that the suggestions are built upon that individual’s experiences and skill level.
  • the system 10 can recommend reloads or products based on historic usage by a specific surgeon, specialty, procedure, and/or patient demographics.
  • the system 10 can include virtual kitting recommendations based on procedure, patient conditions, and/or surgeon preference (based on what is recommended or what the surgeon has been using in past similar experiences).
  • the system 10 can provide statistical data corresponding to what other surgeons have used during a similar operation. Algorithms can be used to provide a product recommendation or common practices to the surgeon (e.g. 30% of cases start with a green reload on a sleeve).
  • the system 10 can notify a user if they are using a product in a method inconsistent with typical usage (e.g., incorrect type of reload in a first sleeve firing). Additionally, the system 10 can determine if an energy device is operating outside of recommended operation parameters since the energy device was scanned earlier in the procedure. Even further, the system 10 can provide a recommendation for a shaft length based on patient characteristics or port placement, specifically in robotic procedure where port placement and anatomy location are known.
  • the system 10 can operate to provide additional data corresponding to instruments selected for a surgical procedure.
  • the system 10 can also determine optimized operational parameters based on the historical usage of the instrument.
  • the system 10 can provide optimized operating parameters based on an intended use to initiate optimized device customizations.
  • a surgical stapler can have operating parameters which are customized due to the use of an unused cartridge, instead of using a reloaded cartridge, where the system 10 can enable the device to accommodate the degradation of a reloaded cartridge.
  • the sled degradation over use can impact staple height and therefore be coupled with wait time or speed to minimize the impact on staple height.
  • the system 10 can determine a custom device calibration that detects losses for the endocutter to allow the system 10 to instruct motor operation differently in order to provide the user a consistent device response to differing tissues even across variable build instruments.
  • the system 10 can provide energy device customization, where custom details of the transducer are provided to the generator/HUB 50 to update the control programs. This customization is due to the fact that each transducer has slightly different harmonic and electronic aspects due to its construction and prior usage which are recorded within the transducer as a calibration and operational parameters. These parameters enable the generator to adjust its drive parameters to customize performance for each individual combination.
  • Examples of operational parameters which can be adjusted include an operational temperature or impedance/frequency data as a means for limiting or calibrating thermal implications. Also, the blade construction and specific dimensions/tolerances/connection of the blade to a transducer can be provided to the system 10 to update the control programs of the endocutter. Even further, the initial clamp force measurement can be used to update the control programs.
  • the system 10 can also be used to compare expected measurements with actual measurements. For example, a transducer has a specific number of cycles for which it can be energized. The transducer has internal electronics that counts each re-use, where a re-use is counted after a predetermined amount of time energized is exceeded so that just plugging a transducer in and immediately unplugging it does not trigger a use count. When a transducer is used, the system 10 can capture total power through the system 10, record frequency, impedance, capacitance, phase margin, power displacement.
  • the battery compartment circuit With the packaging constantly powered, the battery compartment circuit is always in contact with battery and powers a sensor without interruption for tracking sensors or transceivers that record shipping or storage events throughout a lifecycle. For example, temperature history, a countdown timer for shelf life tracking, accelerometer for shock/impact levels.
  • the packaging With the packaging powered on demand, the connections between the battery and packaging circuit only happens at a purposeful time when activated by a user. It can be a switch or electronic signal to begin transmitting and tracking. This can conserve battery capacity and be used for specific on-demand indicators like showing battery level, or for time-sensitive activities like connecting to a HUB 50 for a procedure.
  • the packaging When activated, the packaging can actively look for HUB 50 system and automatically register the device into a hub tracking system to identify the device type, verify the expiration status, and check for compatibility against other associated accessories (like between staplers and cartridges).
  • Electronic activation can occur through a passive tag (RFID or NFC) in the packaging that is held a short distance away from a battery and antenna. When activating this tag, the user physically changes a configuration of the packaging to send current through a circuit to ping the tag, which then sends a signal wirelessly out from the packaging to a HUB 50 or other receiver systems containing packaging or device information.
  • RFID passive tag
  • An example of activating the power supply of the packaging can be in the form of a magnetic switch.
  • a magnetic element inside the sterile packaging can be configured to slide between first and second configurations.
  • a transport system 1300 can include a transport container 1302, which contains a plurality of packaging 1308.
  • the packaging 1308 are stacked on top of one another such that, when a packaging 1308 is removed from the lower compartment 1304, the next packaging slides downward into the compartment 1034.
  • the compartment 1304 can be accessed by opening the door 1306.
  • the user places a magnet 1310 in close proximity to exterior of packaging 1308 and slides the element to change the configuration and connect the battery. As shown in FIG.
  • the packaging 1038 can include an instrument compartment 1354, a battery compartment 1356, a battery 1358 having leads 1359, and a control circuit 1360.
  • the magnet 1310 can be embedded in the door 1306, and positioned in a way to slide the battery 1358 and leads 1359 towards the control circuit 1360 in order to complete the circuit, while removing the packaging 1308 from the transport container 1302.
  • a spring-loaded switch can be held by a magnet in the storage container, and then when a packaging is removed from the storage container, the magnet stops holding the circuit open.
  • the spring is made from folded parts of the packaging itself.
  • the packaging has a dedicated battery separate from the device arranged within the packaging, where the dedicated batter is only present to power the packaging.
  • the battery compartment may contain an indicator for packaging battery power, for example a small LED that indicates there is sufficient current remaining in the dedicated battery to transmit information.
  • the dedicated packaging battery may contain a pull tab to protect the battery from draining when not desired, for example during shipping.
  • the pull tab remains inside sterile barrier, but is accessed by manipulating an exterior surface to allow covering of battery contacts until a user removes the tab.
  • a packaging system 1400 can include a packaging 1402.
  • a bubble 1404 can be formed in the packaging 1402.
  • a portion of the blister of the packaging 1402 is formed into a bubble 1404 that allows it to be popped in or out.
  • the first configuration depicted in FIG. 17, where the bubble 1404 is popped out allows the battery 1406 to be disconnected from the circuit leads 1408.
  • the bubble 1404 is pressed into the packaging 1402, which causes physical connect between the battery 1406 and the leads 1408, allowing a circuit within the packaging 1402 to be powered.
  • the bubble position may be reversible to connect or disconnect battery 1406 (for example, if unintentionally pressed or to deactivate signal transmission).
  • the packaging battery may be rechargeable battery that is able to be charged quickly to a level needed to transmit a signal.
  • the charging can be accomplished by placing the packaging on a wireless battery charger using wireless charging technology in the operating room as part of the normal process of bringing devices into the operating room.
  • the packaging can contain a battery within the packaging to power transceivers and sensors. However, a battery exposed directly to radiation during a sterilization process can be damaged.
  • a packaging contains a separate, connective and reactive power source, which is electrically isolated in a sub-packaging compartment. This separate power source provides power to transceivers and sensors but can be removed during a sterilization process.
  • a power source can be connectively re-engagable.
  • two physical bodies that need to be reconnected within the sterile boundary of the packaging itself such as a loose battery and battery plug in different compartments, can be reconnected by manipulating the outside of the packaging.
  • insertion of a primary packaging into a secondary packaging can connect together a battery and its corresponding leads to provide power without compromising sterility.
  • the act of combining primary and secondary packaging physically connects the packaging and mechanically completes the circuit. A user can push them together, and then slide them to break away a plastic area that will open the connectors to allow the circuit to be complete.
  • the power source is reactively re-engagable.
  • all of the wires can be built into the packaging wall that includes a plastic pull-tab, which acts as a barrier to interrupt the electrical connection between the power supply and sensors until the tab is removed.
  • a current is created within conductive components via the radiation that can destroy sensitive electrical components within circuits. Therefore, the circuits are configured to remain disconnected while the packaging is receiving gamma radiation.
  • a container of acid can be arranged between two barriers such that once the container is crushed, the chemical acid dissolves the barrier and fuses the circuit.
  • the packaging has many primary uses, as outlined above, such as compatibility and authentication-checking processes
  • the packaging can also be multi-use packaging that has a secondary use independent from the first use.
  • a primary use of the packaging can be the product identification.
  • a secondary use of the packaging can include reuse prevention and detection, device disassembly assistance, return the device return, device cleaning (such as including a basin or chemical to clean a harmonic blade when in use by a user or post procedure prior to return), quick trouble shooting, and/or assembly or disassembly guidance.
  • the assembly or disassembly guidance for example, can include separated compartments with text/images of where components need to be placed for return, and include replaceable components with a guide as to how to replace/install those components.
  • a single scanable code can be contained on both a device and a packaging.
  • a single code is printed onto two different substrates, where each substrate contains an incomplete portion. The first portion may be printed on a clear, or see-through substrate. There can also be a position datum needed to orient substrate 1 to substrate 2 below it. Substrate 2 contains the missing information of the single code, so that when scanned, the complete code is provided only when both are present and oriented correctly. The code is needed to activate or track a device system. Without a code, the system is not registered.
  • Each scanable static codes can be arranged on at least two components (for example, the packaging and the endocutter), where each code can be read separately to provide one set of information (such as the date of manufacture, the type of device, the expiration date). But when the two codes are stacked or arranged to be read together, additional information can be accessed (like authentication code that assures the device has not been reprocessed).
  • a packaging tray which is nearly transparent, has a partial QR code printed thereon. The device within the packaging has a portion of the QR code, so that the two codes added together form the complete code.
  • the system 10 can also prevent the reuse of data stored in the packaging.
  • a single use sensor can be arranged on the packaging, and is destroyed when the packaging is opened.
  • the packaging peel can contain part of the sensor or circuit that is broken when the packaging is opened.
  • a lid peels away from plastic tray, where the circuit is partially printed on the tray, with an interruption in the area that the lid is glued.
  • the lid contains a conductive filament that interconnects that interruption while sealed. The act of peeling will remove the jumper and interrupt the circuit.
  • the lid can contain a bar code is printed on an area of the lid that is peeled, so that code is no longer legible once the packaging is opened.
  • the code is positioned on two different sides of a pouch, in the glued zone. Once the code is broken and illegible, the device cannot be scanned into the procedure, limiting its ability to take advantage of digital solutions information.
  • the system 10 can include features that are altered once the packaging is opened.
  • opening the packaging can expose an initially concealed extra bar (as part of bar code) that can change how it is read.
  • a portion of the bar code can become visible after sterilization.
  • photochromic inks can be sued as well on the exterior of the packaging.
  • oxidization chemical exposure can cause a change to a bar code, where the packaging includes a portion of a bar code that is environmentally sealed from both the interior and external environment. This portion is purged during packing with an inert gas, and opening exposed the portion to O2 or CO2, which erases the ink and causes the bar code to change.
  • the packaging itself can contain a display in order to display the stored metadata within the packaging.
  • a smart packaging label only displays information necessary to a current user (i.e., a packaging can store all kinds of information about its own supply chain, but a doctor only gets information relevant to the doctor).
  • the packaging “knows” what to present to the doctor based on various factors, such as its location in the supply-chain progression, interactions with certain personnel, the type of surgical procedure to be performed, and corresponding accessories and instruments.
  • the smart packaging system 10 can provide a user (e.g., transportation worker, customs officer, warehouse personnel, hospital/facility staff, medical team, etc.) with information concerning itself.
  • the information can be conveyed by the smart packaging system 10 in a number of ways, as will be described below, and the information conveyed can be dependent on a number of factors, including: composition, contents, present location, destination, identity of the user, authorization level, functional capabilities, external stimuli, and more.
  • the smart packaging system 10 can be aware of its historic and future states, as well as its intended usage, throughout its lifecycle. In essence, the smart packaging system 10 can possess an awareness of itself during its lifecycle. This awareness can result in the smart packaging system knowing: 1) its location within a facility supply chain; 2) when it has been received at a medical facility; 3) when it enters a stockroom or storage at the medical facility; 4) when it is requested for usage in a medical procedure; and 5) when it enters an operating room for the requested medical procedure. Each of these aspects of awareness will be further described.
  • Locations that trigger different labels or transmittals of information can include: warehouse, storage, transit, sterilization, supplier distribution center, mode of transit, customs, regional distribution center, local delivery, healthcare facility receiving, store room, operating room, repackaging in an operating room, healthcare facility cleaning/sorting, disposal, reuse, return shipping, etc.
  • the smart packaging system 10 is configured to store its intended destination (e.g., a specific hospital), and to document and store a historic record of its travels as it progresses toward its intended destination. Additionally, the smart packaging system 10 can be configured to determine its location within the pathway to its intended destination.
  • the label can present different information to a current user.
  • a supply-chain progression is depicted in FIG. 4.
  • the display can show the parts, acceptance of parts date, revision number, and calibration/certifi cation data (for components and device).
  • the display can show sterilization data, batch number, stock, FIFO date, and shelf location.
  • the display can show a sender address, truck ID, received address, handling instructions, customs data (e.g., declared value), bill of assembly, and generic title.
  • the display can show a shelf location, number of number in stock (e.g., 1 of 5, 2 of 5, etc.
  • the display can show a location, truck number, delivery time, and distributor invoice. While in a hospital stage 170, the display can show an order number, storage location, and item number of number in stock. While in an operating room stage 180, the display can show an operating room number, procedure time, surgeon ID, patient ID, and device number of number in procedure (e.g., 1 of 4 pieces required for the given procedure).
  • data displayed can be capable of updating along the supply-chain, and is readable by the user without connecting to a HUB 50 or aggregation system 10.
  • an E-ink display that when exposed to a wireless power source (e.g., external electric field) is capable of updating the display from the internal electronic stored information or sensed aspects of the packaging.
  • a wireless power source e.g., external electric field
  • the use of a separated device battery can be used to update the electronics. It can have separate circuit that can have a portion of the packaging that the user interacts with to create a short term power connection that allows the display to update.
  • the packaging can also include environmental adaptation designs to provide additional information to a user.
  • a portion of the label has aspects that are adaptive to environmental conditions of the interior or exterior to the packaging. For example, portions of the label can update due to chemical or thermal reactive events, such as exposure of the contents to different aspects of temperature, humidity, light exposure, or energy radiation. This causes the element to change based on either a maximum short-term dose, or a cumulative exposure level.
  • a simplified mechanical sensor can be used in combination with or as a replacement to a powered sensor on a packaging.
  • a mechanical, non-continuously powered sensor 1506 can be arranged within a packaging 1502 of a packaging system 1500.
  • the sensor 1506 can be arranged in a separate compartment from the instrument 1504, can be activated by a user action at a specific time (such as when the device is scanned before use, or when placed into an inventory), and can be used to instantly check the integrity of the packaging and instrument.
  • Types of physical indicators that take the place of powered sensors can include an accelerometer.
  • the senor 1506 can include a magnet 1501 arranged on a post 1512, which is moveable in all directions. Connected to the post 1512 are springs 1516, which help keep the post 1512 centered relative to a surrounding wall 1514.
  • the surrounding wall 1514 is made of a ferrous material such that if the magnet 1510 comes within close proximity to the surrounding wall 1514, the magnetic force will overcome the force applied to the springs 1516, and the magnet 1510 will stick to the surrounding wall 1514. With the magnetic 1510 connected to the surrounding wall 1514, a user can visually see the packaging has experienced a high-force load above a threshold amount.
  • the packaging can include a circuit which is completed once the magnet 1510 contacts the surrounding wall 1514, sending a signal to a memory within the packaging, recording the exceed threshold as a historical data point.
  • the alert can be presented to a user once the packaging transmits any form of data, or can show directly on a display on the packaging.
  • a spring can be suspended between a circuit and a battery to trip in a force is applied to the packaging beyond a threshold level.
  • the spring can disconnect the battery from the circuit if an experienced force was beyond a threshold amount.
  • a thermally-reactive element 1550 can be used.
  • the thermally reactive elements 1550 can be in the form of a wax-like element arranged within a packaging.
  • the wax-like element 1550 can originally have a specific shape (i.e., rectangle, circle, or specific logo), shown in FIG. 22, that will alter in form, such as melting, warping, and/or cracking, if the packaging is exposed to temperatures outside a minimum or maximum threshold, shown in FIG. 23.
  • an optical UV detector can be used on the packaging.
  • a thin, clear polycarbonate can be arranged in the packaging such that when exposed to light, the polycarbonate yellows or clouds when a threshold of UV is exceeded. Thickness of such polycarbonate sheets can be in a range of 0.015" to 0.025". As explained above, UV exposure can weaken certain components of the packaging and surgical instrument, e.g., certain plastics can become very brittle. UV exposure above a certain threshold can warn an operator that the packaging and/, or surgical instrument may be compromised.
  • Powered alternatives to these mechanical devices can include an accelerometer included in packaging, a thermometer within the device powered by battery in a packaging, and optical sensor to record UV exposure, a barometer, a humidity sensor, or a GPS.
  • each packaging can include a transceiver in the form of an RFID tag to facilitate communication with external systems (e.g. , to allow a stock room to know where a given device is).
  • An RFID tag needs close proximity for energization.
  • the RFIDs in the packaging arranged on the shelf can be energized in order to read the data stored on the RFID tag. This passive reading can be used to notify user of recalled products.
  • the HUB 50 can utilize an interface or stock room layout that powers the display on the packaging to change the E-ink display on the packaging to indicate to the user to not use that specific instrument.
  • the display itself can have a multi-level menu which can be navigated in order to provide addition data not shown on the initial screen of the display.
  • the display can include a scanable code which can direct a user to additional information stored in a cloud database.
  • Some of this information can be region-specific information, such as optimal device performance instructions, other surgeons or experts that use this device in your area, top users in region, local rep contact info, personal message/video from assembly line, device built or component sourced from a local area, connection to Real -world evidence (RWE) studies, complaint automation, geo-location (language specific), a universal complain icon, mistaken use credit offering (send a replacement, for example), rewards points, disposal guidance, compatible devices such as buttresses, reloads, trocars, best practices documents, YouTube instructional videos, or marketing materials.
  • RWE Real -world evidence
  • RWE is a method of gathering information from medical records and other sources in order to determine how a treatment works in practice.
  • the display can also include multiple languages, which can be changed automatically through GPS, or a user command. For example, the product reads English when it is in the US prior to shipment, giving all English shipping instructions, and as soon as the packaging detects it has landed in Germany for example, the display language immediately switches to German.
  • packaging can provide additional data through the use of a smart device or scanner
  • other packaging themselves can also provide additional data to one another such that a combination of packaging provides more information together than an individual packaging can provide separately.
  • a user can gather several packaging together, where the packaging can give the user information related to the packaging as a set (i.e., compatibility, or operating limits), which one packaging cannot do alone.
  • the system 10 can ensure cooperative packaging are interlocking, nesting or seat together for a surgical procedure.
  • the system 10 can detect the color, shape, outline, theme, and features of a device once the packaging is scanned or enters the operating room using any of the methods described herein. This allows the system 10 to confirm that all pulled packaging contain compatible instruments and accessories.
  • the displays on the packaging themselves can also provide a message to a user that a specific cartridge needs to be used with a specific stapler. This way, a user can collect all necessary, compatible packaging prior to a surgical procedure starting.
  • FIG. 24 is a schematic view of a stomach 1600 undergoing a gastric sleeve surgical procedure.
  • a plurality of staple sets 1602, 1604, 1606, 1608 need to be stapled to the stomach. Due to the volume of staples used in the procedure, the stapler will be required to be reloaded in order to complete the procedure. Additionally, the staple set may be different depending on their required operating parameters corresponding to their location on the stomach 1600. As depicted in FIG.
  • a display 1612 on packaging can be altered by the system 10 to alert the user to collect the corresponding staples as well, and for what surgery the stapler and staples are needed for.
  • the display 1612 can also display to a user the corresponding location where the packaging 1610 can be arranged in operating room.
  • an operating room may contain a table 1620 having openings 1626, which packaging 1610 seat into in order to confirm all compatible products are present in the operating room.
  • the table 1620 can include an upper portion 1622 and a lower portion 1624.
  • the accessories, such as staples can be arranged in the top portion 1622, and the instruments which utilize the accessories can be arranged in the lower portion 1624.
  • the table 1620 can also be used for loading the accessories into the instruments.
  • the displays 1630, 1632, 1634, 1636 on each packaging can provide to a user the firing order of each staple cartridge, and can also provide a warning if an incorrect packaging is arranged in the table 1620.
  • two compatible packaging 1640, 1642 can be used for a procedure.
  • the display 1644 of the packaging 1640 can provide a user with a warning to return the packaging 1640 to the opening 1626 if a user has removed the packaging 1640.
  • the system 10 can alter the message provided on the display 1646 of the packaging 1642 to insert the packaging 1642 into the opening 1626, since both packaging 1640, 1642 can be used for a surgical procedure.
  • the system 10 can track combinations of product usage pairings to optimize patient outcome.
  • the system 10 can provide feedback, such as a comparison of what packaging were pulled compared to the packaging that are returned/unused. This information can be used to inform hospital administrators of device use trends. In order to provide more data, when a packaging is returned without being used, a reason can be included on why it was pulled/returned. Examples of messages can include (1) device was pulled as a "just in case” (2) redundant pull (3) usually I use it (4) found alternate device.
  • Approximating language may be applied to modify any quantitative representation that can permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about,” “approximately,” and “substantially,” are not to be limited to the precise value specified. In at least some instances, the approximating language may correspond to the precision of an instrument for measuring the value.
  • range limitations may be combined and/or interchanged, such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise.

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Abstract

Des systèmes et des procédés sont proposés. Les systèmes comprennent un emballage chirurgical stérile scellé par le fabricant contenant un instrument chirurgical configuré pour être utilisé lors d'une intervention chirurgicale, un affichage graphique, au moins un processeur de données en communication fonctionnelle avec l'affichage graphique, et une mémoire en communication fonctionnelle avec le ou les processeurs de données, et stockant des instructions configurées pour amener le ou les processeurs de données à effectuer des opérations. Les opérations peuvent consister à stocker des paramètres correspondant à l'instrument chirurgical, à recevoir un ensemble de données caractérisant des paramètres associés à l'instrument chirurgical, à régler, sur la base des données reçues, les paramètres catalogués, à déterminer une représentation graphique caractérisant les paramètres réglés, et à fournir la représentation graphique des paramètres réglés sur l'affichage graphique.
EP24742325.4A 2023-07-07 2024-07-08 Systèmes d'emballage intelligents avec stockage élastique non volatil Pending EP4573568A1 (fr)

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US202363525572P 2023-07-07 2023-07-07
US18/479,461 US20250014727A1 (en) 2023-07-07 2023-10-02 Smart packaging systems with nonvolatile resilient store
PCT/IB2024/056618 WO2025012786A1 (fr) 2023-07-07 2024-07-08 Systèmes d'emballage intelligents avec stockage élastique non volatil

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EP24743045.7A Pending EP4552131A1 (fr) 2023-07-07 2024-07-08 Système et procédé d'échange de données sélectivement réglable entre un boîtier intelligent et un système demandeur
EP24742323.9A Pending EP4566070A1 (fr) 2023-07-07 2024-07-08 Systèmes et procédé d'échange de données sélectivement réglable entre un boîtier intelligent et un système demandeur
EP24743047.3A Pending EP4552132A1 (fr) 2023-07-07 2024-07-08 Système et procédés de gestion virtuelle de stock
EP24742322.1A Pending EP4552137A1 (fr) 2023-07-07 2024-07-08 Systèmes et procédés de création et de gestion de kits virtuels
EP24742325.4A Pending EP4573568A1 (fr) 2023-07-07 2024-07-08 Systèmes d'emballage intelligents avec stockage élastique non volatil
EP24743046.5A Pending EP4562653A1 (fr) 2023-07-07 2024-07-08 Système et procédé d'échange de données sélectivement réglable entre un boîtier intelligent et un système demandeur
EP24743913.6A Pending EP4566065A1 (fr) 2023-07-07 2024-07-08 Systèmes et procédés de détermination de compatibilité de dispositif chirurgical
EP24742324.7A Pending EP4558999A1 (fr) 2023-07-07 2024-07-08 Systèmes et procédés de stockage et de transfert de métadonnées d'emballage intelligent

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EP24742323.9A Pending EP4566070A1 (fr) 2023-07-07 2024-07-08 Systèmes et procédé d'échange de données sélectivement réglable entre un boîtier intelligent et un système demandeur
EP24743047.3A Pending EP4552132A1 (fr) 2023-07-07 2024-07-08 Système et procédés de gestion virtuelle de stock
EP24742322.1A Pending EP4552137A1 (fr) 2023-07-07 2024-07-08 Systèmes et procédés de création et de gestion de kits virtuels

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EP24743913.6A Pending EP4566065A1 (fr) 2023-07-07 2024-07-08 Systèmes et procédés de détermination de compatibilité de dispositif chirurgical
EP24742324.7A Pending EP4558999A1 (fr) 2023-07-07 2024-07-08 Systèmes et procédés de stockage et de transfert de métadonnées d'emballage intelligent

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US20250013972A1 (en) 2025-01-09
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US20250014733A1 (en) 2025-01-09
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EP4562653A1 (fr) 2025-06-04
US20250014724A1 (en) 2025-01-09
US20250014726A1 (en) 2025-01-09
US12164985B1 (en) 2024-12-10
US20250014736A1 (en) 2025-01-09
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US20250014723A1 (en) 2025-01-09
US20250014734A1 (en) 2025-01-09
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US20250014735A1 (en) 2025-01-09
US20250014728A1 (en) 2025-01-09
US20250014727A1 (en) 2025-01-09
US12493765B2 (en) 2025-12-09
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US20250014725A1 (en) 2025-01-09

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